The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a problem is to arise during a clinical trial, those who use a quality management system are more easily able to provide the necessary records to the FDA, because documentation is virtually processed in the system. A quality management system allows virtual biotech companies to remain accountable throughout the oversight of clinical trial development. Essentially, implementing a quality management system reduces risk and helps achieve compliance, all the while streamlining operations and increasing efficiency.
How the FDA Defines Quality in Biotech and Biopharma
Quality guidelines established by the FDA, called GxP, were implemented to ensure that products developed in regulated industries go through rigorous and effective research practices, meet standard and secure manufacturing, storage, and distribution processes, and result in safe high-quality products that meet their intended use for the end consumer.
Generally in biotech and biopharma industries, quality products are considered defect free, not contaminated, and composed of the properties defined on respective labels. According to the FDA, patients and caregivers expect their products to be safe, consistent, and labeled correctly, among many other things. In order to meet those FDA regulations and consumer standards, managing quality processes for a company in the preclinical to early clinical stages of development is critical.
FDA Quality Management Standards for Virtual Biotech Companies
Quality management is a high priority for companies in regulated industries, such as virtual biotech. The FDA requires quality, consistency, and transparency of data and documentation regarding the performance and oversight of clinical trials. Sponsors must establish a Quality System and approve protocols for clinical studies and clinical materials, maintain controlled documents, and inspect issues and deviations. In addition, virtual biotech companies are responsible for negotiating with vendors and contractors while ensuring they are qualified.
The FDA standards by which virtual biotech companies are guided can make an already complex oversight process even more challenging. There is a constant need to implement Continuous Process Improvement principles as a way to ensure product safety and efficacy, keep costs down, and of course provide quality, consistency, and traceability.
Particularly, an FDA compliant quality management and vendor management system designed by drug development experts helps virtual biotech companies comply with responsibilities and FDA regulations. Implementing a robust quality management system fully integrated with a full set of Standard Operating Procedures, templates and forms that work together with incident logs, CAPA logs, and change control and training processes, can assure quality processes for virtual biotech companies.
What InstantQMS™ Offers Virtual Biotech Companies
With a quality management solution like InstantQMS™, which was designed by quality and regulatory experts, virtual biotech companies can ensure they are meeting the regulatory and compliance thresholds expected of them. Such a system can be a significant tool for efficiency. A quality management system, such as InstantQMS™, is key to keeping operations moving forward at the right pace and free from errors, which avoids mistakes that could drive up costs.
InstantQMS™ was created with those complexities, and the aim of efficiency, in mind. Users can utilize a full suite of functions, from a multi-faceted incident log that tracks and manages every step of the investigation process to an audit system designed with cybersecurity at the forefront. These capabilities allow for cleaner, speedier and safer quality management, which ultimately supports more successful business outcomes. Through this system, in combination with an optional Learning Management System, users have access to the following tools to meet FDA regulations and better achieve quality standards:
- Incident Log
- Vendor Management
- Audit Log
- Complaint Log
- CAPA Log
- Change Control Log
- Training Log
- Template Storage
With a partner like InstantGMP™, virtual biotech companies have the data and the documentation to ensure their businesses are fully compliant and able to provide the consistency and quality that all of their stakeholders require, which will ultimately drive long-term business performance.
If you’re interested in learning more about InstantQMS™, you can schedule a live demo where our team of experts will demonstrate how your processes can be modeled in our software, as well as talk about the numerous benefits of InstantGMP™.